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1. WO2007098612 - COMPOSITION POUR CAPSULES DE GÉLATINE RÉSISTANTES À L'ACIDE GASTRIQUE ET PROCÉDÉ DE PRODUCTION ASSOCIÉ

Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

[ EN ]

WHAT IS CLAIMED IS:

1. A gastric-resistant gelatin composition for use in the preparation of dosage forms, said gelatin composition comprising:
30-60 % (w/w of the composition) of gelatin;
0.1-10 % (w/w of the composition) of a functionalizing agent containing a carboxylate group or an acyl chain containing group, said functionalizing agent comprising i) a carboxylate group or an acyl chain containing group, and a reactive group capable of reacting the gelatin for attaching covalently said carboxylate group or said acyl chain containing group to the gelatin; and
0.1-10 % (w/w of the composition) of a negatively charged polysaccharide.

2. The gelatin composition of claim 1 , further comprising 0.5-15% (w/w of the composition) of a lipid.

3. The gelatin composition of claim 1 , further comprising 0.5-10% (w/w of the composition) of an emulsifier.

4. The gelatin composition of any one of claims 1 to 3, wherein the polysaccharide is selected from the group consisting of alginate, hyaluronate, pectin, carrageenan, xanthan, and galactomanan or combination thereof.

5. The gelatin composition of any one of claims 1 to 3, wherein the polysaccharide is alginate.

6. The gelatin composition of any one of claims 1 to 3, wherein the lipid is selected from the group consisting of fatty acids, preferably stearic acid, oleic acid and palmitic acid, mineral oils, vegetal oils, preferably canola oil, Nn oil, soybean oil, and polycaprolactone.

7. The gelatin composition of any one of claims 1 to 3, wherein the emulsifying agent is selected from the group consisting of ionic and amphoteric compounds.

8. The gelatin composition of claim 7, wherein the emulsifying agent is selected from the group consisting of zwitterions, phosphatidylcholin, phosphatidylserine, phosphatidyl ethanolamine, and phsphatidylinositol, or a mixture thereof.

9. The gelatin composition of any one of claims 1 to 3, wherein the gelatin is porcine gelatin, bovine gelatin or fish gelatin, obtained from either skin, bones or cartilage.

10. The gelatin composition of any one of claims 1 to 3, wherein the functionalizing agent comprising a carboxylate group is selected from the group consisting of succinic anhydride, glutaric anhydride, maleic anhydride, isovaleric anhydride, diglycolic anhydride, and monochloracetic acid.

11. The gelatin composition of any one of claims 1 to 3, wherein the functionalizing agent comprising an acyl chain containing group is selected from the group consisting of acyl chloride, anhydride of fatty acids, dodecenylsuccinic anhydride, nonenylsuccinic anhydride, and 2- dodecen-1-yl-succinic anhydride.

12. The gelatin composition of claim 11 , wherein the acyl chloride is selected from the group consisting of palmitoyl chloride, steroyl chloride, and myristoyl chloride.

13. The gelatin composition of claim 11 , wherein the anhydride of fatty acids is selected from the group consisting of myristic anhydride, palmitic anhydride, erucic anhydride, and heptanoic anhydride.

14. The gelatin composition of any one of claims 1 to 3, wherein the functionalizing agent is succinic anhydride.

15. The gelatin composition of any one of claims 1 to 3, further comprising at least one other ingredients selected from the group consisting of a plastifier, an antibacterial agent, a flavoring agent, a coloring agent, a sweetener, and an antioxidant.

16. The gelatin composition of claim 15, wherein said plastifier is selected from the group consisting of glycerol, propylen glycol, and sorbitol.

17. The gelatin composition of claim 15, wherein said antibacterial agent is selected from the group consisting of propionic acid, sorbic acid, and benzoic acid.

18. The gelatin composition of claim 15, wherein said antioxidant is selected from the group consisting of butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT).

19. Use of the gelatin composition as defined in any one of claims 1 to 18, for the manufacture of a dosage form selected from the group consisting of capsules, spheres, films, and hydrogels.

20. Use of the gelatin composition as defined in any one of claims 1 to 18, for encapsulating or entrapping a bioactive agent.

21. The use of claim 20, wherein the bioactive agent in selected from the group consisting of a bioactive peptide, a protein, bacteria, and a pharmaceutical drug.

22. A method for manufacturing a gelatin composition for use in the preparation of dosage forms, said method comprising the steps of: i) dispersing 30-60 % (w/w of the composition) of gelatin in a solution of 0.1-10 % (w/w of the composition) of a negatively charged polysaccharide to create an emulsion; and

ii) stirring into said emulsion 0.1-10 % (w/w of the composition) of a functionalizing agent containing a carboxylate group or an acyl chain containing group and a reactive group capable of reacting the gelatin for attaching covalently said carboxylate group or said acyl chain containing group to the gelatin, for a time sufficient for said functionalizing agent to attach covalently said carboxylate group or said acyl chain containing group to the gelatin to obtain an emulsion of functionalized gelatin in the solution of the negatively charged polysaccharide.

23. The method of claim 22, further comprising in step i) the addition of 0.5- 15% (w/w of the composition) of a lipid before dispersing said gelatin in the solution.

24. The method of claim 23, further comprising in step i) the addition of 0.5- 10% (w/w of the composition) of an emulsifier before dispersing said gelatin in the solution.

25. The method of any one of claims 22 to 24, wherein the polysaccharide is selected from the group consisting of alginate, hyaluronate, pectin, carrageenan, xanthan, and galactomanan or a combination thereof.

26. The method of any one of claims 22 to 24, wherein the polysaccharide is alginate.

27. The method of any one of claims 22 to 24, wherein the lipid is selected from the group consisting of fatty acids, preferably stearic acid, oleic acid and palmitic acid, mineral oils, vegetal oils, preferably canola oil, lin oil, soybean oil, and polycaprolactone.

28. The method of any one of claims 22 to 24, wherein the emulsifying agent is selected from the group consisting of ionic and amphoteric compounds.

29. The method of claim 28, wherein the emulsifying agent is selected from the group consisting of zwitterions, phosphatidylcholin, phosphatidylserine, phosphatidyl ethanolamine, and phsphatidylinositol, or a mixture thereof.

30. The method of any one of claims 22 to 24, wherein the gelatin is porcine gelatin, bovine gelatin or fish gelatin, obtained from either skin, bones or cartilage.

31. The method of any one of claims 22 to 24, wherein the functionalizing agent comprising a carboxylate group is selected from the group consisting of succinic anhydride, glutaric anhydride, maleic anhydride, isovaleric anhydride, diglycolic anhydride, and monochloracetic acid.

32. The method of any one of claims 22 to 24, wherein the functionalizing agent comprising an acyl chain containing group is selected from the group consisting of acyl chloride, anhydride of fatty acids, dodecenylsuccinic anhydride, nonenylsuccinic anhydride, and 2- dodecen-1-yl-succinic anhydride.

33. The method of claim 32, wherein the acyl chloride is selected from the group consisting of palmitoyl chloride, steroyl chloride, and myristoyl chloride.

34. The method of claim 32, wherein the anhydride of fatty acids is selected from the group consisting of myristic anhydride, palmitic anhydride, erucic anhydride, and heptanoic anhydride.

35. The method of any one of claims 22 to 24, wherein the functionalizing agent is succinic anhydride.

36. The method of any one of claims 22 to 24, further comprising a step iii) of adding an additive selected from the group consisting of a plasticizer an antibacterial agent, a flavoring agent, a coloring agent, a sweetener, and an antioxidant.

37. The method of claim 36, wherein said plasticizer is selected from the group consisting of glycerol, propylen glycol, and sorbitol.

38. The method of claim 36, wherein said antibacterial agent is selected from the group consisting of propionic acid, sorbic acid, and benzoic acid.

39. The method of claim 36, wherein said antioxidant is selected from the group consisting of butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT).

40. A method for manufacturing a gelatin composition for use in the preparation of dosage forms, said method comprising the steps of:

i) Contacting 0.1-10 % (w/w of the composition) of a functionalizing agent containing a carboxylate group or an acyl chain containing group and a reactive group capable of reacting the gelatin for attaching covalently said carboxylate group or said acyl chain containing group to the gelatin, with a solution of 30-60 % (w/w of the composition) of gelatin for a time sufficient for said functionalizing agent to attach covalently said carboxylate group or said acyl chain containing group to the gelatin to obtain a solution of functionalized gelatin; and

ii) Adding to the solution of functionalized gelatin a solution of 0.1-10 % (w/w of the composition) of a negatively charged polysaccharide for completing said composition.

41. The method of claim 41 , further comprising at step ii) the addition of 0.5-15% (w/w of the composition) of a lipid to the negatively charged polysaccharide.

42. The method of claim 42, further comprising at step ii) the further addition of 0.5-10% (w/w of the composition) of an emulsifier to the negatively charged polysaccharide.

43. The method of any one of claims 40 to 42, wherein the polysaccharide is selected from the group consisting of alginate, hyaluronate, pectin, carrageenan, xanthan, and galactomanan or a combination thereof.

44. The method of any one of claims 40 to 42, wherein the polysaccharide is alginate.

45. The method of any one of claims 40 to 42, wherein the lipid is selected from the group consisting of fatty acids, preferably stearic acid, oleic acid and palmitic acid, mineral oils, vegetal oils, preferably canola oil, lin oil, soybean oil, and polycaprolactone.

46. The method of any one of claims 40 to 42, wherein the emulsifying agent is selected from the group consisting of ionic and amphoteric compounds.

47. The method of claim 46, wherein the emulsifying agent is selected from the group consisting of zwitterions, phosphatidylcholin, phosphatidylserine, phosphatidyl ethanolamine, and phsphatidylinositol, or a mixture thereof.

48. The method of any one of claims 40 to 42, wherein the gelatin is porcine gelatin, bovine gelatin or fish gelatin, obtained from either skin, bones or cartilage.

49. The method of any one of claims 40 to 42, wherein the functionalizing agent comprising a carboxylate group is selected from the group consisting of succinic anhydride, glutaric anhydride, maleic anhydride, isovaleric anhydride, diglycolic anhydride, and monochloracetic acid.

50. The method of any one of claims 40 to 42, wherein the functionalizing agent comprising an acyl chain containing group is selected from the group consisting of acyl chloride, anhydride of fatty acids, dodecenylsuccinic anhydride, nonenylsuccinic anhydride, and 2- dodecen-1-yl-succinic anhydride.

51. The method of claim 50, wherein the acyl chloride is selected from the group consisting of palmitoyl chloride, steroyl chloride, and myristoyl chloride.

52. The method of claim 50, wherein the anhydride of fatty acids is selected from the group consisting of myristic anhydride, palmitic anhydride, erucic anhydride, and heptanoic anhydride.

53. The method of any one of claims 40 to 42, wherein the functionalizing agent is succinic anhydride.

54. The method of any one of claims 40 to 42, further comprising a step iii) of adding an additive selected from the group consisting of a plastifier, an antibacterial agent, a flavoring agent, a coloring agent, a sweetener, and an antioxidant.

55. The method of claim 54, wherein said plastifier is selected from the group consisting of glycerol, propylen glycol, and sorbitol.

56. The method of claim 54, wherein said antibacterial agent is selected from the group consisting of propionic acid, sorbic acid, and benzoic acid.

57. The method of claim 54, wherein said antioxidant is selected from the group consisting of butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT).